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The FDA was not impressed with Korean devicemaker Dexcowin’s responses to a Form 483 it received following an August 2017 inspection of its facility in Seoul. The agency received two responses from the manufacturer of portable dental X-rays, but then issued a 13-item warning letter. Read More
FDA investigators uncovered numerous quality system deficiencies during a December 2017 inspection of Laser Dental Innovations’ San Jose, California plant. Read More
The inspector reviewed 123 complaints related to reports of infections and/or deaths for which the company had not opened corrective or preventive action files. Read More
Class II device manufacturer Arrowhead Dental was cited for failure to develop design control and medical device reporting procedures among other quality failures in a Form 483 issued following a December 2017 inspection of the firm’s Sandy, Utah facility. Read More
Smith & Nephew drew a Form 483 for multiple issues at its Memphis, Tennessee facility, including a faulty procedure for the control of nonconforming product and inadequate corrective and preventive action procedures. Read More
The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products. Read More
The FDA cited ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Read More